Blizzards and user fees
This article was originally published in The Gray Sheet
Executive Summary
FDA said it will extend congressionally-mandated decision deadlines for devices and drugs whose Medical Device User Fee Act (MDUFA) or Prescription Drug User Fee Act (PDUFA) decision goals came due during or shortly after the extreme winter storms that swept through Washington, D.C., and shut down FDA offices earlier this month. FDA is extending the deadline for user fee decisions due the weeks of Feb. 8 and Feb. 15 by up to four business days for devices and five business days for drugs. Further, product submissions that would normally have been received during the closure will not be marked as "received," for purposes of starting the regulatory clock, until the FDA center resumes normal operations
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Global Pharma Guidance Tracker – March 2024
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